Customizable medical electrode

ABSTRACT

A medical electrode includes a conductive member having a top and a bottom side and a plurality of cutouts establishing a pattern of islands interconnected by conductive member bridges. A plurality of island electrodes are provided with each island electrode disposed on a corresponding island. A conductive adhesive is disposed on the conductive member bottom side for adhering the medical electrode to a patient&#39;s skin.

The present application is a divisional patent application based uponU.S. Ser. No. 12/796,561, now pending. This '561 application is to beincorporated herewith in its entirety by this specification referencedthereto.

The present invention generally relates to electrodes and, moreparticularly, electrodes suitable for transcutaneous nerve and/or musclestimulation and biological signal recording.

With regard to transcutaneous nerve and/or muscle stimulation, medicalelectrodes must provide an even electrical distribution to a patient'sskin over an entire surface of the electrode to effect proper coupling.Because of the curvaceous nature of the human body, it is apparent thatmedical electrodes for use thereon must be flexible not only forconfirmation with a patient's skin contours, but also to accommodaterelative movement of the patient's skin.

It is well known that inadequate flexing and shaping of the electrode toa patient's contour can result in an irritation of the patient's skin.Electrical “hot spots” due to uneven electrode-skin contact can resultin a rash or a burning sensation. A sensation of burning may be felt bya patient within a few minutes after application of the electricalsignals during nerve and/or muscle stimulation, while rash conditionsgenerally take a longer period of time to develop.

In order to provide uniform electrical coupling, methods have heretoforebeen developed utilizing conductive fabrics and foils in combinationwith a conductive adhesive in order to uniformly couple electricalsignals to and/or from an electrical lead wire, or connector.

A number of such electrodes have provided impedance compensation fordirecting electrical pulses from the lead wire uniformly throughout anelectrode. For example, see U.S. Pat. No. 5,038,796 entitled, ELECTRICALSTIMULATION ELECTRODE WITH IMPEDANCE COMPENSATION, as well as U.S. Pat.No. 7,324,847, U.S. Pat. No. 5,904,712 CURRENT CONTROLLING ELECTRODE toAxelgaard.

As a further example, U.S. Pat. No. 4,736,752 teaches the control ofcurrent density across an electrode through the use of conductive inkdesign areas. These patents are incorporated in their entirety herewithby this specific reference thereto.

Many prior art electrodes have compromised the flexibility of theelectrode in order to provide adequate current densities over the entirecontact area of the electrode. Such electrodes typically have utilized ametallic mesh, or foil, to provide conductivity and utilize a conductivegel between the electrode and the patient's skin in order to accommodatethe movement therebetween. Such use of foil or mesh often cause burningor hot spots at electrode edges.

The present invention is directed to a medical electrode and a methodhaving a pattern of island electrodes interconnected in a mannerenabling adaptation to various body parts by energizing selectivenumbers of island electrodes in a desired pattern for each of thevarious body parts.

A method for delivering electrode stimulation to a body generallyincludes a medical electrode in accordance with the present inventiongenerally includes a conductive member having a top and a bottom sideand a plurality of cutouts generally establish a pattern of islandsinterconnected by conductive member bridges.

A plurality of island electrodes may be disposed on either the top orbottom side of the conductive member and on a corresponding island ashereinafter described, in greater detail.

A conductive adhesive may be disposed on the conductive member bottomside and covering the island electrodes disposed on the bottom side andalso for adhering a medical electrode to a patient's skin. When theisland electrodes are disposed on the top side of the conductive memberadhesive it is present for adhering medical electrode to a patient'sskin and transfer of electrical pulse thereto and therefrom.

Conductivity may be controlled in a number of manners. First, theconductive adhesive may be disposed on the conductive member only on theislands or alternatively can be disposed on the islands and the bridges.Further, the width of the bridges are narrower than the islands in orderto provide electrode flexibility and also to control conductivitybetween the island electrodes.

Conductivity may be further controlled when the conductive member isanisotropic having lower conductivity in a plane of the member comparedto the transverse conductivity. Alternatively, the conductive adhesivemay be an anisotropic having lower conductivity in a plane of theadhesive compared to transverse conductivity.

Various configurations of islands are contemplated, for example, theislands and island and electrodes may be rectilinear and the bridgesinterconnect the islands at sides thereof. Alternatively, the islandsand island electrodes may be rectangular and the bridges interconnectthe islands at corners thereof. Other geometric configurations are to heconsidered as included in the present application.

In addition, an indicia may be disposed on each bridge for indicatingbridge severability options in order to provide a selected stimulationpattern to a patient.

SUMMARY OF THE INVENTION

A method of use of the electrode in accordance with the presentinvention includes selecting a body part for application of theelectrode, severing selected bridges of the electrode corresponding tothe selected body part, connecting at least one electrode contact pointwith an outside electronic device and applying the electrode to the bodypart.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention may be better understood with reference to thefollowing detailed description taken in conjunction with theaccompanying drawings in which:

FIG. 1 is a bottom plan view of an electrode in accordance with thepresent invention generally showing a conductive member with a pluralityof cutouts establishing a honeycomb pattern of islands interconnected byconductive member bridges along with a plurality of island electrodeswith each island disposed on the conductive member bottom side;

FIG. 2 is an exploded cross sectional view of the electrode shown inFIG. 1 additionally showing a conductive adhesive disposed on theconductive member bottom side;

FIG. 3 is a plan bottom view of an alternative electrode in accordancewith the present invention for generally showing a conductive memberhaving a top and a bottom side and a plurality of cutouts establishing ahoneycomb islands interconnected by conductive member bridges;

FIG. 4 is an exploded cross sectional view of the electrode shown inFIG. 3 also illustrating a plurality of island electrodes with each ofthe island electrodes being disposed on the conductive member top side;

FIG. 5 is a plan bottom view of yet another embodiment of the presentinvention showing a clustered island arrangement for enablingconfirmation with a selected body part;

FIG. 6 is a plan bottom view of still another embodiment of the presentinvention illustrating an alternative clustered island array; and

FIG. 7 is a representation of the use of an election in accordance withthe present invention.

DETAILED DESCRIPTION

With regard to FIGS. 1 and 2, there is shown a medical electrode 10 inaccordance with the present invention which generally includes aconductive member 14 having a top side 18 and a bottom side 20.

A connector 24 may be provided with a lead wire 26 and jack 28 forestablishing electrical connection with the conductive member 14.

The conductive member 14 includes a plurality of cutouts whicheffectively creates a pattern of islands 36 interconnected by conductivebridges 40.

Also shown in FIGS. 1 and 2 are a plurality of island electrodes 44disposed on corresponding conductive member islands 36 on the conductivemember bottom side 20.

The island electrodes 44 may be ink patterns as described in U.S. Pat.No. 7,324,847 hereinabove referenced and incorporated herewith whichalso describes the formulation of the conductive member 14 which may beformed from any suitable carbon loaded elastomeric film. Alternatively,the electrode 44 may be formed from any suitable metal, conductivecoating or conductive plastic.

The bridges 40 are narrower than the islands 36 to provide electrode 10flexibility in order to contour the electrode 10 to any body part (notshown).

With reference to FIG. 2, a conductive hydrogel adhesive 50 is disposedon the conductive member bottom side 20 which covers the islandelectrodes 44 and also adheres a medical electrode 10 to a patient'sskin (not shown).

A plastic, paper, or other suitable carrier 54 along with a releasecoating 56 may be provided to prevent inadvertent and/or prematureadhesion of the patient's skin or other object to the adhesive 50. Thecarrier 54 and release coating 56 are removed prior to application ofthe electrode 10 to the patient's body part (not shown).

Conductivity between the island electrodes 44 and a user's body part(not shown) may be controlled in a number of structural configurations.For example, the conductive adhesive 50 may be disposed only on theislands 36, or alternatively disposed on both the islands 36 and thebridges 40.

In addition, the conductive member 14 may be anisotropic having a lowerconductivity in the plane of the member 14 compared to transverseconductivity. Alternatively, the conductive adhesive 50 may beanisotropic having a lower conductivity in the plane of the adhesivecompared to transverse conductivity. Such flexible members and adhesiveshaving anisotropic properties are available from 3M, St, Paul, Minn.,see product data bulletin 73-73, “Grounded Heat Sink Bonding Film”,September 2001, technical data sheet “Z-Axis Adhesive Film” March 2003and technical Bulletin “Anisotropic Conductive Film Adhesive” January2007. These references are to be incorporated herewith in their entiretyfor describing suitable films and adhesives for use in the presentinvention.

With further reference to FIG. 2, a cover sheet 58 and adhesive 60 maybe provided to both insulate the conductive member 14 and attach thelead wire 26 to the conductive member 14.

An important feature of the present invention is the severability of thebridges 40 by a scissors, knife, or any suitable cutting device in orderto create an active pattern of island electrodes 44 when provided withelectrical impulses through non-severed bridges 40.

Various patterns of severability are indicated by indicia 62, seeFIG. 1. Indicia 62 shown are not descriptive of any preferable severingof the bridges 40 but only illustrated as to the indication by way ofink or colored indicia to set forth the principal of the invention.

The indicia 62 may include various patterns of different colors in orderto sever the bridges 40 in a particular manner so that the electrode 10may be applied to a specific body part, for example, an arm, an elbow, awrist or a leg, a knee, an ankle with proper island electrode placementand activity for proper direction of electrical impulses into theselected body part (FIG. 7).

Accordingly, a method in accordance with the present invention using theelectrode 10 includes selecting a body part (not shown) for applicationof the electrode 10 severing selected bridges 40 of the electrodecorresponding to the selected body part, connecting at least oneelectrode contact point through the connector 24 to an outsideelectronic device and applying the electrode 10 to the selected bodypart.

The present invention is not limited to the geometric configurationshown in FIG. 1 which includes rectangular islands 36 and rectangularprimary electrodes 44 interconnected by bridges 40 at corners 66 of theislands 36.

An alternative example of an electrode 80 is shown in FIGS. 3 and 4 withcommon reference numbers indicating identical or substantially similarelements hereinabove described in connection with the electrode 10 shownin FIGS. 1 and 2. In this embodiment, a conductive member 84 having atop side 86 and bottom side 88 (see FIG. 4) with cutouts 94 establishinga honeycomb pattern of islands 98 with bridges 102 interconnecting theislands 98 at sides 106 thereof.

As shown in FIG. 4, in the electrode 80 island electrodes 110 aredisposed on the top side 86 of the conductive member 84.

The remaining elements of the electrode 80 are indicated with referencecharacters common with those hereinabove described in connection withthe electrode 10.

With reference to FIGS. 5 and 6, there are shown alternative electrode120, 122 embodiments with the common reference characters relating to aequivalent or substantially similar elements of the electrode 10 shownin FIGS. 1 and 3. A conductive member 124 is provided with cutouts 126to define a cluster 132 of islands 134, 136 which are arrangedconfirmation with a selected body part, not shown. Each of the islands134, 136 include island electrodes 140, 142 as herein described inconjunction with the embodiments 10 and 80.

Bridges 150, similar to those hereinbefore described, interconnect theisland electrodes 140, 142 to the conductive member 124. The size andshape of the islands 134, 136 and island electrodes 140, 142 areselected for providing a stimulation pattern into a selected body part,not shown, when deployed.

As hereinabove noted, indicia 160 disposed on each bridge 150 providefor indicating bridge 150 severability options in order to provide aselected pattern of active electrodes 140, 142 for providing stimulationto a body part, not shown. Only a limited number of indicia 160 areindicated in FIGS. 5 and 6 in order to provide a representation of thisfeature. All of the bridges 150 may be provided with indicia 160 whichmay be in the form of any color, numerical denotation, or mark enablingrecognition of severability points for utilizing the medical electrode120. In addition, the cluster 132 is provided only for illustrationpurposes and that many other clusters (not shown) may be utilizeddepending upon the ultimate positioning desired of the electrode 120 ona body part, not shown.

The size and shape of the islands 134, 136 and electrodes 140, 142 arealso only representative with any number of size, shape, islands shape,island electrodes (not shown) considered to fall within the scope of thepresent invention.

A method for delivering stimulation including providing a medicalelectrode which, in turn includes a conductive member having a top and abottom side and a plurality of cutouts establishing a pattern of islandsinterconnected by severable conductive member bridges, a plurality ofisland electrodes, each island electrode disposed on a correspondingisland, a conductive adhesive disposed on the conductive member bottomside for adhering the medical electrode to a patient's skin, indiciadisposed on each bridge for indicating bridge severability options inorder to provide a selective stimulation pattern to the patient, aplurality of spaced apart contact points enabling connection of saidplurality of island electrodes to at least one electronic device,selecting a body part for application of the electrode, severingselected bridges of the electrode corresponding to the selected bodypart, connecting at least one electrode contact point with an outsideelectronic device, applying the electrode to the selected body part; andapplying electronic stimulating current to the contact point.

Although there has been hereinabove described a honeycomb or clustertype medical electrode in accordance with the present invention for thepurpose of illustrating the manner in which the invention may be used toadvantage, it should be appreciated that the invention is not limitedthereto. That is, the present invention may suitably comprise, consistof or consist essentially of the recited elements. Further, theinvention illustratively disclosed herein suitably may be practiced inthe absence of any element which is not specifically disclosed herein.Accordingly, any and all modifications, variations or equivalentarrangements which may occur to those skilled in the art, should beconsidered to be within the scope of the present invention as defined inthe appended claims.

1-25. (canceled)
 26. A method for delivering stimulation includingproviding a medical electrode which, in turn includes a conductivemember having a top and a bottom side and a plurality of cutoutsestablishing a pattern of islands interconnected by severable conductivemember bridges, a plurality of island electrodes, each island electrodedisposed on a corresponding island, a conductive adhesive disposed onthe conductive member bottom side for adhering the medical electrode toa patient's skin, indicia disposed on each bridge for indicating bridgeseverability options in order to provide a selective stimulation patternto the patient, a plurality of spaced apart contact points enablingconnection of said plurality of island electrodes to at least oneelectronic device, selecting a body part for application of theelectrode, severing selected bridges of the electrode corresponding tothe selected body part, connecting at least one electrode contact pointwith an outside electronic device, applying the electrode to theselected body part; and applying electronic stimulating current to thecontact point.
 27. A method of using the electrode according to claim26, said method comprising: selecting a body part for application of theelectrode; severing selected bridges of the electrode corresponding tothe selected body part; connecting at least one electrode contact pointwith an outside electronic device; and applying the electrode to theselected body part.
 28. The medical electrode according to claim26wherein said conductive adhesive is disposed on the conductive memberonly on said islands.
 29. The medical electrode according to claim26wherein said conductive adhesive is disposed on the conductive memberon said islands and the bridges.
 30. The medical electrode according toclaim 26wherein said plurality of island electrodes are selected from agroup consisting of conductive ink, metal, conductive coating, andconductive plastic.
 31. The medical electrode according to claim26wherein said bridges are narrower than the islands to provideelectrode flexibility and control conductivity.
 32. The medicalelectrode according to claim 26wherein said conductive member isanisotropic having lower conductivity in a plane of the member comparedto transverse conductivity.
 33. The medical electrode according to claim26wherein said conductive adhesive is anisotropic having lowerconductivity in a plane of the adhesive compared to transverseconductivity.
 34. The medical electrode according to claim 26wherein theisland electrodes are disposed on the conductive member bottom side andare covered by the conductive adhesive.
 35. The medical electrodeaccording to claim 26wherein the island electrode are disposed on theconductive member top side.
 36. The medical electrode according to claim26wherein the islands and island electrode are clustered forconformation with a selected body part.
 37. The medical electrodeaccording to claim 26wherein the islands and island electrodes are ofdifferent sizes.
 38. The medical electrode according to claim 26furthercomprising indicia disposed on at least some of the bridges forindicating bridge severability options in order to provide a selectedpattern of active electrodes.
 39. A medical electrode for deliveringelectric stimulation in selected stimulation patterns to a patient, saidmedical electrode comprising: a conductive member having a top and abottom side and a plurality of cutouts establishing a pattern of islandsinterconnected by severable conductive member bridges; a plurality ofisland electrodes, each island electrode disposed on a correspondingisland; a conductive adhesive disposed on the conductive member bottomside for adhering the medical electrode to a patient's skin; and indiciadisposed on at least some of the bridges for indicating bridgeseverability options in order to provide a selected stimulation patternto the patient.
 40. The medical electrode according to claim 40 whereinsaid conductive adhesive is disposed on the conductive member only onsaid islands.
 41. The medical electrode according to claim 40 whereinsaid conductive adhesive is disposed on the conductive member on saidislands and the bridges.
 42. The medical electrode according to claim 40wherein said plurality of electrodes are selected from a groupconsisting of conductive ink, metal, conductive coating, and conductiveplastic.
 43. The medical electrode according to claim 40 wherein saidbridges are narrower than the islands to provide electrode flexibilityand control conductivity.
 44. The medical electrode according to claim40 wherein said conductive member is anisotropic having lowerconductivity in a plane of the member compared to transverseconductivity.
 45. The medical electrode according to claim 40 whereinsaid conductive adhesive is anisotropic having lower conductivity in aplane of the adhesive compared to transverse conductivity.
 46. Themedical electrode according to claim 40 wherein the island electrodesare disposed on the conductive member bottom side and are covered by theconductive adhesive.
 47. The medical electrode according to claim 40wherein the island electrode are disposed on the conductive member topside.
 48. The medical electrode according claim 40 wherein the islandsand island electrode are clustered for conformation with a selected bodypart.
 49. The medical electrode according to claim 40 wherein theislands and island electrode are of different sizes.